PROPER
Research type
Research Study
Full title
Pan-EU Real-World Experience with Imraldi®
IRAS ID
262253
Contact name
Deepak Jadon
Contact email
Sponsor organisation
Biogen International GmbH
Eudract number
2019-000937-38
Clinicaltrials.gov Identifier
TBC, Clincaltrials.gov
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Being proposed is a phase IV observational, prospective and retrospective real-world cohort multi-centre study of Imraldi®. There will be no clinical interventions as part of this study, the standard of care patient pathway will be uninterrupted. All data needed to fulfil the study objectives will be provided through normal clinical practice. Imraldi® is already being used in patients with immune-mediated inflammatory disease such as Rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC). No single site or subject is expected to contribute to all study variables. Over the past 15 years, biologic therapy has become a valuable addition to the range of therapeutic drug classes available to treat these patients.\n\nThe study will enrol subjects who are currently on or about to start taking Imraldi® for any of the above indications. \n\nDue to its large scope the study will be undertaken in several departments at each site and or within multiple indication clinics where available. \n\nEach site will have a Principal Investigator assigned with Co-Investigators in order to ensure effective oversight and expertise across all indications involved.\n\nThe primary objective of this observational study is to capture early data on patient experience of Imraldi® and the drug’s utilisation within routine clinical management of patients.\n\nSecondary objectives:\n\n•\tClinical characteristics of the study population at baseline\n•\tImraldi® drug utilisation \n•\tImraldi® drug effectiveness (how well it maintains clinical stability)\n•\tRoutine laboratory and clinical evaluation measurements (blood tests and where relevant,stool samples)\n•\tUse of relevant concomitant medication (with a focus on immunosuppressant drugs, steroids and other biologics other than Imraldi®\n•\tImmunogenicity (how the immune system responds to Imraldi®)\n•\tSafety
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0141
Date of REC Opinion
29 Apr 2019
REC opinion
Favourable Opinion